Abstract

Background: Menorrhagia i.e., excessive menstrual blood loss is a common problem that interferes with women’s physical, emotional, social and material quality of life. Unani physicians have mentioned so many herbal formulations to treat menorrhagia. This study was aimed to compare the efficacy of polyherbal unani formulation and tranexamic acid on menorrhagia. Materials & Methods: This prospective randomized single blind standard controlled trial was conducted in Department of Niswan wa Qabala, National Institute of Unani Medicine. 40 patients were assigned to test (20) and control (20) groups. Both the test as well as control was given orally for five days from first day of menstrual cycle for two consecutive cycles. Assessment of efficacy was based on pictorial blood loss assessment chart (PBAC) to assess the amount of blood loss. Hb% and quality of life were also assessed as secondary outcome. Chi-square/ Fisher Exact test has been used to find the significance of study parameters on categorical scale between groups. Results: There was no significant difference found between the groups on all parameters assessed which shows that the test drug can be an alternative for tranexamic acid after clinical trial on large sample size and for longer duration. Conclusion: Test drug has been found having equal effect with tranexamic acid. There is need for further study on large sample size.

Keywords

Menorrhagia; Polyherbal; Anti-haemorrhagic

Introduction

Heavy flow during periods is called menorrhagia or kasrate tams
and it is one of the most common reasons for women to be referred to
gynecologists. It is the main presenting problem in at least half of those
who undergo hysterectomies [1]. Prevalence of menorrhagia is
approximately 10% to 15% in women of reproductive age [2]. It has
two conditions, either flow increases in amount or duration [3,4].

Indeed, the associated discomfort, anxiety and impaired quality of
life lead many women to surgical procedures, ranging from
endometrial ablation to hysterectomy, often in the absence of any
detectable pathology [5]. Several drug classes are recommended for the
treatment of heavy menstrual bleeding (HMB); however, most of them
are not accepted by patients because of either failure in controlling the
bleeding or side-effects [6].

Unani physicians have stated that in kasrate tams excessive flow of
blood is mainly due to two causes that is weakness in quwate masika
(retentive power) or increase in quwate dafiya (excretory power) or
both. Cause of weakness of quwate dafiya is any type of sue mizaj
(abnormal temperament), mainly sue mizaj haar yabis (hot & dry), which causes weakness of uterus and its vessels and leads to opening of
mouth of vessels and rupture of vessels.

Cause of excess functioning of quwate dafiya (excretory power) is
due to khilt lazaa, hararat and hiddat (excess heat) of blood. This
hiddat and lazaa again causes opening of mouth of blood vessels [7,8].

In unani literature numbers of drugs are available single as well as in
compound form to treat haemorrhage. Almost same drugs have also
been mentioned for menorrhagia. These drugs are effective to control
bleeding by having its haemostatic and astringent property e.g.,
anjabar, geru, sange jarahat, dammul akhwain, etc. [9,10]. A polyherbal unani formulation sharbate anjbar is the most popular and most
common composition to treat haemorrhage [11-13].

Sharbate anjbar is available with different formulations which are
being used from many years for haemorrhage. So considering the
above fact, the present study was carried out in Dept. of Ilmul Qabalat
wa Amraze Niswan, NIUM Hospital, Bangalore, to scientifically
evaluate the efficacy of sharbate anjbar in the management of
menorrhagia.

Materials and Methods

A prospective single blind randomized standard controlled study
was conducted in the Dept. of Ilmul Qabalat wa Amraze Niswan,
NIUM Hospital, Bangaluru from November 2014 to March 2015 to
compare the efficacy of polyherbal unani formulation and tranexamic
acid on menorrhagia. The study protocol was approved by Institutional
Ethical Committee, NIUM Bangalore.

Inclusion criteria were married as well as unmarried women of
reproductive age group complaining of heavy menses with regular
cycles. Patients with irregular and inter-menstrual bleeding, patient
suffering from systemic illness, blood dyscrasias, malignancy and
severe anaemia (Hb% less than 7.5 g), unwillingness or inability to
comply the requirements of the protocol were excluded from the study.

In each patient, history was evaluated and a complete physical
examination including breast and abdominal examination and per
vaginal (in married patients) examination was performed. Personal
details, history, clinical features and investigations were recorded in the
case record form (CRF) structured for the study.

After a control cycle, (Figure 1) total of 40 patients meeting the
inclusion criteria were randomly assigned to test (20 patients) and
control (20 patients) groups after explaining the study in detail and
receiving the informed consent. Randomization was done by using
computer generated random table.

Figure 1: Flow diagram of the participants.

For the test group a polyherbal syrup formulation sharbate anjbar was selected which contains beekhe anjbar, aqaqia, sandal surkh, and
sandal sufaid. These drugs were purchased from local drug retailer of
Bangalore by purchase committee and were identified by Dept. of
Pharmacology, NIUM.

Syrup was prepared in pharmacy of this institute according to the
standard unani method of preparation and given in the dose of 25 ml
BD for 5 days during menses from the first day of menstrual cycle for
two consecutive cycles. In the control group standard drug tranexamic
acid 500 mg BD was also given for 5 days from the first day of
menstrual cycle for two cycles. Assessment of blood loss during
periods was done by PBAC score and assessment in improvement of
quality of life was done by SF-36 score.

Patients were assessed for two consecutive cycles during the
treatment and one cycle after the treatment. During treatment amount
of bleeding were assessed by asking duration of cycle, amount of flow
which was assessed by calculating the total no. of pads used in one
cycle and duration of flow from both the groups.

Apart from that improvement in quality of life was assessed by using
SF-36 questionnaire before and after treatment. Effectiveness of trial
drugs were assessed by Pictorial blood loss assessment chart (PBAC
score) to assess the amount of blood loss, SF-36 score to asses quality of
life and improvement in Hb%.

Chi-square/Fisher Exact test has been used to find the significance
of study parameters on categorical scale between groups.

Results and Discussion

Baseline demographic profile was same between the two groups
with p value >0.05 (Table 1). As shown in Table 2, baseline PBAC
score in test group was 496.55 ± 256.37 and in control score was 595.70
± 379.76 which is not significant between the groups with p value of
0.339. During first treatment cycle score was calculated as 160.30 ±
54.20 in test group and 257.25 ± 257.77 in control group with p value
of 0.108. During second cycle 124.65 ± 46.57 score was calculated in
test group and 220.95 ± 246.06 in control group which is statistically
significant between the groups with p value of 0.094. During after
treatment follow up cycle the score was calculated as 109.50 ± 38.50 in
test group and 291.85 ± 483.95 in control group which is not
significant with p value 0.101. Mean difference in groups were found
387.05 in test group and 303.85 in control group.

Characteristic

Test group

Control group

P value

No

%

No

%

Age(years)

Nov-20

5

25

3

15

21-30

9

45

8

40

31-40

4

20

7

35

P=0.787

41-50

2

10

2

10

Total

20

100

20

100

Marital status

Married

11

55

14

70

Unmarried

9

45

6

30

P=0.327

Total

20

100

20

100

Occupation

Employed

1

5

1

5

House wife

10

50

16

80

Student

9

45

3

15

P=0.100

Total

20

100

20

100

SES

Lower

0

0

1

5

Lower middle

9

45

5

25

Upper lower

5

25

8

40

P=0.699

Upper middle

5

25

5

25

Upper

1

5

1

5

Total

20

100

20

100

Habitat

Rural

1

5

2

10

Urban

19

95

18

90

P=1.000

Total

20

100

20

100

Diet

Mixed

17

85

18

90

Veg.

3

15

2

10

P=0.633

Total

20

100

20

100

Table 1: Baseline demographic of the patients with menorrhagia in test and control group.

PBAC Score

Test group

Control group

P value

Baseline

496.55 ± 256.37

595.70 ± 379.76

0.339

First cycle

160.30 ± 54.20

257.25 ± 257.77

0.108

Second cycle

124.65 ± 46.57

220.95 ± 246.06

0.094+

After treatment follow up

109.50 ± 38.50

291.85 ± 483.95

0.101

Difference

387.05

303.85

-

P value (Before –After)

<0.001**

<0.001**

-

Table 2: PBAC Score of patients studied.

In present study it is obvious that the test drug has almost equal
effect with control drug in improvement of PBAC score. PBAC score to
assess the menstrual blood loss has been used in various previous
studies conducted. Jaisamrarn et al. [14] has showed a significant
decrease in PBAC score from 350.5 to 178.6 with 49% decrease in
mean menstrual blood flow after two cycles which was significant. One
more study conducted by Lee et al. [15] showed significant reduction
in PBAC score from 262.0 to 125.0 with 47.4% decrease in mean
menstrual blood flow.

Significant improvement in PBAC score in test group is attributed
due to haemostatic property of sharbate anjbar by which it reduces
bleeding [11-13]. Ingredients of sharbate anjbar contains tannin, gallic acid, ellagic acid and flavonoids which are potential styptic and
astringent there by reduces heavy menstrual blood loss [7,10,16-19]. Acacia arbica one of the ingredients has also been studied for its
coagulation property in the mice [20]. Another study has shown that Acacia arabica along with Moringa oleifera are haemostatic and hasten
blood coagulation [21].

Table 3 shows mean SF-36 score. Before treatment it is 233.75 ±
90.42 in test group and 185.55 ± 61.06 in control group with a p value
of 0.055 and after treatment it is calculated as 777.70 ± 35.65 in test
group and 697.15 ± 161.89 in control group with p value of 0.036.
Mean difference is 543.95 in test group and 511.60 in control group.
On inter group comparison before treatment findings were suggestive
significant (p value: 0.05<p<0.10) in both the groups. After treatment
findings were moderately significant with p value of (p value: 0.01<p ≤
0.05). In test group drug was found more effective in improving quality
of life than control group.

SF-36 Score

Test group

Control group

P value

Before treatment

233.75±90.42

185.55±61.06

0.055+

After treatment

777.70±35.65

697.15±161.89

0.036*

Difference

543.95

511.6

-

P value (Before –After)

<0.001**

<0.001**

-

Table 3: SF-36 Score of patients studied.

Menorrhagia is a common gynecological condition that has a
significant impact on the wellbeing and quality of life of many
women’s. In present study SF-36 questionnaire was used to evaluate the
impact of treatment on women’s quality of life and it is obvious that
test drug is significant in improving women’s quality of life. These
findings are similar with the studies conducted by Pattison et al. [22]
and Marjoribanks et al. [23]. In these studies, significant improvement
in quality of life was observed after treatment.

Table 4 is showing improvement in Hb% in mean ± SD. Baseline Hb
% was found 11.71 ± 1.45 in test group and 11.66 ± 1.54 in control
group with p value of 0.908 and after two treatment cycles it was found
11.96 ± 1.43 in test group and 11.56 ± 1.68 in control group with p
value of 0.428. On intergroup comparison after treatment findings
were not significant (p>0.05). On intra group comparison findings
were also not significant (p>0.05) but in test group drug was found
more effective in improving Hb% than control group. Besides these no
adverse effect was found in both the groups.

SF-36 Score

Test group

Control group

P value

Before treatment

233.75±90.42

185.55±61.06

0.055+

After treatment

777.70±35.65

697.15±161.89

0.036*

Difference

543.95

511.60

-

P value (Before –After)

<0.001**

<0.001**

-

Table 4: Hemoglobin % of patients studied.

Limitation of the study

Small sample size.

Conclusion

Present study shows that sharbate anjabar is found to have almost
equal effect with tranexamic acid on all the parameters studied but
sample size was small so study on large sample size is needed before
keeping it as an alternative for menorrhagia.